Investment in biosafety and biosecurity: the need for a risk-based approach and systematic reporting of laboratory accidents to mitigate laboratory-acquired infections and pathogen escapes
Authors: Stuart D Blacksell, Kathrin Summermatter, Zibusiso M Masuku, Kazunobu Kojima, Emma Ross, David R Harper, Keith Hamilton
Journal: The Lancet Microbe (2023)

In the realm of high-consequence pathogens, laboratory-acquired infections (LAIs) and accidental pathogen escapes from laboratories can have far-reaching and severe implications for individuals, animals, and the environment. These occurrences are a great concern for a wide range of stakeholders, including laboratory workers, managers, those in the scientific research community and industry, policy makers, political leaders, and the general public. It is vitally important to take all necessary measures to mitigate the risks associated with such occurrences as the consequences of these events can be significant and long-lasting. Therefore, understanding the frequency and causes of laboratory accidents via the use of a systematic and transparent reporting mechanism is essential. To reduce the occurrence of accidental pathogen escapes, experts recommend implementing an evidence-based approach that prioritises risk-based biosafety, biosecurity, and biocontainment while supporting laboratory sustainability.1Kimman TG Smit E Klein MR Evidence-based biosafety: a review of the principles and effectiveness of microbiological containment measures.Clin Microbiol Rev. 2008; 21: 403-425Crossref PubMed Scopus (0) Google Scholar This method is favoured over a one-size-fits-all approach, which is often inflexible and expensive to implement and maintain. A risk-based approach to biosafety management ensures safety for staff and the community by focusing on pathogen transmission routes, manipulations or procedures, and individuals.2Kojima K Booth CM Summermatter K et al.Risk-based reboot for global lab biosafety.Science. 2018; 360: 260-262Crossref PubMed Scopus (12) Google Scholar This approach is recommended by WHO3WHOLaboratory biosafety manual, 4th edn.https://www.who.int/publications/i/item/978924001131Date: 2020Date accessed: September 18, 2023Google Scholar and the World Organisation for Animal Health,4World Organisation for Animal HealthBiosafety and biosecurity: standard for managing biological risk in the veterinary laboratory and animal facilities.in: Manual of diagnostic tests and vaccines for terrestrial animals. World Organisation for Animal Health, Paris2018: 48-63Google Scholar culminating in the Biosafety Research Road Map initiative to identify evidence gaps to guide applied biosafety research.5Blacksell SD Dhawan S Kusumoto M et al.The biosafety research road map: the search for evidence to support practices in human and veterinary laboratories.Appl Biosaf. 2023; 28: 64-71Crossref PubMed Scopus (1) Google Scholar However, resistance to change, unfamiliarity, lack of evidence, and differing understandings of the guidelines can pose challenges when implementing this approach. Furthermore, the availability of adequately trained biosafety professionals experienced in the application of this risk-based approach is frequently limited in low-resource hospital and veterinary laboratory settings. The occurrence of accidents resulting in LAIs or pathogen escapes is frequently attributed to errors or deficiencies in procedural protocols, highlighting the need for continuous improvement through root-cause analysis of the underlying causes. This approach should help to minimise the risk of LAIs and associated accidents and ensure that laboratory safety is a top priority in the future. Notably, such an approach would depend on (and promote) the formal reporting of laboratory mishaps and occurrences in a non-punitive manner. In addition, a process of documenting infectious pathogen exposure events not resulting in LAIs, together with near misses, should enhance our understanding of adverse occurrences that are preventable through mitigation-control strategies. Although many nations might be without structured and open reporting systems, where they do exist, they can serve as useful examples. In the USA, reporting of laboratory-related incidents is required under the Occupational Safety and Health Act of 1970, which requires all employers to ensure that workplaces provide safe and healthful working conditions.6Occupational Safety and Health AdministrationUS Department of LaborOccupational Safety and Health Act of 1970.https://www.osha.gov/laws-regs/oshact/completeoshactDate accessed: September 18, 2023Google Scholar Under this Act, employers are required to report illnesses and injuries, although these are not necessarily investigated. In the case of the US Federal Select Agent Program, which administers high-consequence pathogens and toxins (known as biological select agents and toxins), the regulations require the immediate reporting of exposure, LAI, or any release outside of a primary containment device.7Gonder JC Select agent regulations.ILAR J. 2005; 46: 4-7Crossref PubMed Scopus (6) Google Scholar Elsewhere, the Public Health Agency of Canada has implemented the Laboratory Incident Notification Canada surveillance system,8Thompson E El Jaouhari M Eltayeb N et al.Surveillance of laboratory exposures to human pathogens and toxins, Canada, 2021.Can Commun Dis Rep. 2022; 48: 484-491Crossref Google Scholar the Singapore Ministry of Health has the Biological Agents and Toxins Act 2005 for the reporting of adverse incidents or activities,9Singapore Ministry of HealthIncident/activities report.https://www.moh.gov.sg/biosafety/common/notifications/incident-activities-reportDate: 2019Date accessed: August 29, 2023Google Scholar and the UK's Health and Safety Executive has the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013.10Health and Safety ExecutiveReporting accidents and incidents at work. A brief guide to the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013 (RIDDOR).https://www.hse.gov.uk/pubns/indg453.pdfDate: 2013Date accessed: March 15, 2023Google Scholar To enable the greater sharing of information, these national reporting systems could inform the development of a transparent global reporting system, perhaps under the auspices of the appropriate multilateral international organisations, based on a no-blame model. Such a system could also benefit from the lessons learned from the nuclear and aircraft industries, for example, which emphasise continual improvement. On a global scale, investing in risk-based biosafety as part of a broader laboratory core management competency is of the utmost importance. However, there is a scarcity of skilled personnel with applied knowledge who can conduct risk-based assessments. Therefore, it is essential to invest in trained biosafety professionals who can advocate for adequate staffing for biosafety oversight, regulatory compliance, and transparent incident and accident reporting. The integration of accessible biosafety training programmes into higher education curricula is critical for changing the mindset and behaviour of future laboratory workers. Even in well resourced environments, the biosafety field does not have a formalised organisational structure and defined career paths, and there remains debate regarding whether credentials should be based on on-the-job experience, formal qualifications, or a combination of both.11Gillum D The making of a biosafety officer.Issues Sci Technol. 2023; 39: 67-71Crossref Google Scholar The successful implementation of global risk-based biosafety and biosecurity measures requires both political will and substantial investment in human resources and systems. Only then will a safer environment for laboratory staff and the public be achieved. The authors wish to thank David Elliott, UK International Biosecurity Programme, UK, for his input to this Comment and his contributions to the Biosafety Research Roadmap initiative. The Weapons Threat Reduction Program of Global Affairs Canada provided funding for this study. This research was funded in whole, or in part, by the Wellcome Trust (220211). The donors played no role in the writing of the manuscript or the decision to submit it for publication. We declare no competing interests. The authors alone are responsible for the views expressed in this Comment, and they do not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated.